Varivax

WARNINGS

PRECAUTIONS

General

Adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactoid reaction occur.

The duration of protection from varicella infection after vaccination with VARIVAX (varicella virus vaccine live) is unknown.

It is not known whether VARIVAX (varicella virus vaccine live) given immediately after exposure to natural varicella virus will prevent illness.

Vaccination should be deferred for at least 5 months following blood or plasma
transfusions, or administration of immune globulin or varicella zoster immune
globulin (VZIG).24

Following administration of VARIVAX (varicella virus vaccine live) , any immune globulin, including VZIG, should
not be given for 2 months thereafter unless its use outweighs the benefits of
vaccination.24

Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination
with VARIVAX (varicella virus vaccine live) as Reye's Syndrome has been reported following the use of salicylates
during natural varicella infection (see CLINICAL
PHARMACOLOGY, Reye's Syndrome).

The safety and efficacy of VARIVAX (varicella virus vaccine live) have not been established in children and
young adults who are known to be infected with human immunodeficiency viruses
with and without evidence of immunosuppression (see also CONTRAINDICATIONS).

Care is to be taken by the health care provider for safe and effective use of VARIVAX (varicella virus vaccine live) .

The health care provider should question the patient, parent, or guardian about reactions to a previous dose of VARIVAX (varicella virus vaccine live) or a similar product.

The health care provider should obtain the previous immunization history of the vaccinee.

VARIVAX (varicella virus vaccine live) should not be injected into a blood vessel.

A separate sterile needle and syringe should be used for administration of each dose of VARIVAX (varicella virus vaccine live) to prevent transfer of infectious diseases.

Needles should be disposed of properly and should not be recapped.

Transmission

Post-marketing experience suggests that transmission of vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from vaccinees without a varicella-like rash has been reported but has not been confirmed.

Therefore, vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to six weeks. In circumstances where contact with high-risk individuals is unavoidable, the potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural varicella virus. Susceptible high-risk individuals include:

pregnant women without documented history of chickenpox or laboratory evidence
of prior infection

newborn infants of mothers without documented history of chickenpox or laboratory
evidence of prior infection.

Carcinogenesis, Mutagenesis, Impairment of Fertility

VARIVAX (varicella virus vaccine live) has not been evaluated for its carcinogenic or mutagenic potential,
or its potential to impair fertility.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted
with VARIVAX (varicella virus vaccine live) . It is also not known whether VARIVAX (varicella virus vaccine live) can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. Therefore,
VARIVAX (varicella virus vaccine live) should not be administered to pregnant females; furthermore, pregnancy
should be avoided for three months following vaccination (see CONTRAINDICATIONS).

Nursing Mothers

It is not known whether varicella vaccine virus is secreted in human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if VARIVAX (varicella virus vaccine live) is administered to a nursing woman.

Geriatric Use

Clinical studies of VARIVAX (varicella virus vaccine live) did not include sufficient numbers of seronegative
subjects aged 65 and over to determine whether they respond differently from
younger subjects. Other reported clinical experience has not identified differences
in responses between the elderly and younger subjects.

Pediatric Use

No clinical data are available on safety or efficacy of VARIVAX (varicella virus vaccine live) in children
less than one year of age and administration to infants under twelve months
of age is not recommended.